BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELFOAM SIZE 100 SPONGE

    MDR report key: 1964028 · Received January 12, 2011

    Report

    Report Number
    MW5019025
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    PFIZER
    Product Code
    LMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    GELFOAM SPONGE SIZE 100 -(B)(4)- PACKAGING IS NOT OPENING PROPERLY. THE ENVELOPE IS NOT PULLING APART THE WAY IT IS DESIGNED TO OPEN. RATHER, THE PACKAGE IS TEARING IN AN IRREGULAR FASHION WHICH MAKES IT IMPOSSIBLE TO REMOVE THE SPONGE ASEPTICALLY IN THE OPERATING ROOM. THIS FORCES THE PRODUCT TO BE DISCARDED AND WASTED AND ANOTHER PACKAGE TO BE USED. THIS HAS NOT BEEN OCCURRING UNTIL RECENTLY AND IT HAS BEEN HAPPENING WITH SOME REGULARITY OVER THE LAST MONTH (LOT 0BBFT EXP 06/2013). WE SPECULATE THAT THERE MAY HAVE BEEN A CHANGE IN ADHESIVE BEING USED TO SEAL THE ENVELOPES IN MFG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELFOAM SIZE 100 SPONGE GELFOAM SIZE 100 SPONGE LMF PFIZER OBBFT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other